RecruitingPHASE2INTERVENTIONAL

Stereotactic Ablative Radiotherapy (XRT) and Immunotherapy for Oligometastatic Extracranial Melanoma

This study is exploring a new way to treat advanced melanoma, a type of skin cancer that has spread to other parts of the body. We're looking at whether combining a special type of radiation therapy, called Stereotactic Ablative Radiotherapy (SBRT), with standard immunotherapy works better than immunotherapy alone. SBRT uses highly focused X-rays to target and destroy cancer cells while protecting healthy tissue. Immunotherapy helps your body's own immune system fight the cancer. Both treatments are used for melanoma, but this study aims to find out if using them together improves how well the treatment works and helps people live longer.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Melanoma Institute Australia

Enrolment target

129

Start

06 Mar 2025

Estimated completion

01 Apr 2033

Melanoma Metastatic

What is this study about?

This research is focused on people who have advanced melanoma, meaning the cancer has spread to other areas of the body. We want to learn if adding a special type of radiation treatment to the standard immunotherapy drugs they receive could be more effective.

Radiation therapy uses high-energy X-rays to kill cancer cells. The type of radiation used in this study, called Stereotactic Body Radiotherapy (SBRT), is very precise. It focuses strong beams of radiation directly onto the melanoma, helping to destroy the cancer cells without harming too much of the surrounding healthy parts of your body. Immunotherapy works differently; it helps your body's own defence system, called the immune system, to recognize and fight the cancer.

Both radiation and immunotherapy are often used to treat melanoma. But doctors are interested in finding out if giving them together might be more powerful. The main goal of this study is to see if combining these two treatments can shrink the melanoma more effectively and help people live longer, compared to receiving immunotherapy on its own.

Key takeaways

This study compares combined radiation and immunotherapy to immunotherapy alone for advanced melanoma.
The type of radiation used is highly targeted to specific cancer areas.
It aims to see if combining treatments improves patient outcomes.
Participation involves receiving either combined treatment or immunotherapy only.
Regular monitoring and follow-up will be part of the study.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a type of melanoma that has spread to other parts of your body, but not to your brain. You also need to be well enough to receive treatment, which your doctor will assess. The melanoma should be in one to five main areas outside of your brain, and we need to be able to measure at least one of these spots.

There are some reasons why you might not be able to join. For example, if your melanoma started in your eye or in certain inner linings of your body (like the mouth or nose), this study wouldn't be right for you. Also, if you need urgent radiation therapy for symptoms like spinal cord compression, or if you've had radiation for advanced melanoma before, you wouldn't be able to take part. Your medical team will go through all these details with you to make sure the study is a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have melanoma that has spread to other parts of your body, but not your brain?
Do you feel well enough to undergo cancer treatment?
Have you not had radiation therapy for advanced melanoma before?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first have some checks to make sure your treatment is safe and effective. You would then be randomly assigned to one of two groups: one group will receive a special type of radiation therapy combined with immunotherapy, and the other group will receive immunotherapy alone. This random assignment is like flipping a coin, ensuring a fair comparison between the treatments.

The radiation therapy, if you receive it, involves carefully targeted X-rays given over several days, depending on how many areas of melanoma you have. You would also receive regular immunotherapy treatments, which are usually given through a drip. You will have regular appointments and scans to monitor how you are responding to the treatment and to check for any side effects. This will continue for a period, and your doctors will discuss the exact schedule and follow-up plan with you.

Potential risks and benefits

Participating in this study might offer potential benefits, such as a chance for a new treatment combination that could work better than current standard care for advanced melanoma. However, it's also important to be aware of potential risks, including side effects from the radiation or immunotherapy treatments, which your doctor will explain in detail. Your safety is a top priority, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (5)

Westmead Hospital
Verified postcode
Westmead, Australia· Recruiting
Melanoma Institute Australia
Verified postcode
Wollstonecraft, Australia· Recruiting
Princess Alexandra Hospital
Verified postcode
Woolloongabba, Australia· Recruiting
The Alfred Hospital
Verified postcode
Melbourne, Australia· Recruiting
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that starts in skin cells. In advanced melanoma, the cancer cells have spread to other parts of the body.

What is immunotherapy?

Immunotherapy is a treatment that helps your body's own immune system find and fight cancer cells more effectively.

What is 'stereotactic radiation'?

'Stereotactic radiation' is a very precise type of radiation therapy that delivers high doses of X-rays directly to the cancer, aiming to kill cancer cells while protecting healthy tissue nearby.

Why combine radiation and immunotherapy?

Doctors think that giving these two treatments together might boost the body's ability to fight melanoma more effectively than either treatment alone.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of two groups, like flipping a coin, so we can fairly compare the two treatment approaches. You won't know which group you are in.

How to find out more

Monica Osorio

monica.osorio@melanoma.org.au +61 2 9911 7296 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.